UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056097 |
|---|---|
| Receipt number | R000064069 |
| Scientific Title | Registry-based Research of Quantitative Flow Ratio-derived Pullback Pressure Gradient and Angiography-derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2024/11/08 10:17:21 |
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Basic information
Public title
Registry-based Research of Quantitative Flow Ratio-derived Pullback Pressure Gradient and Angiography-derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease
Acronym
Registry-based Research of Quantitative Flow Ratio-derived Pullback Pressure Gradient and Angiography-derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease
Scientific Title
Registry-based Research of Quantitative Flow Ratio-derived Pullback Pressure Gradient and Angiography-derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease
Scientific Title:Acronym
Registry-based Research of Quantitative Flow Ratio-derived Pullback Pressure Gradient and Angiography-derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This registry-based study aims to explore the association between quantitative flow ratio (QFR), pullback pressure gradient (PPG) and angiography-derived index of microcirculatory resistance (Angio-IMR), and clinical presentations and outcomes. As a subgroup analysis, we are planning to examine their relationship with other modalities (guidewire-derived physiological indices, invasive or non-invasive imaging modalities) to clarify the clinical significance of QFR, PPG and Angio-IMR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
none
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent percutaneous coronary intervention with evaluable QFR.
Key exclusion criteria
Patients whose QFR are non-evaluable
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tsunekazu |
| Middle name | |
| Last name | Kakuta |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
300-0028
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
TEL
+81-29-830-3711
kaz@joy.email.ne.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Usui |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
300-0028
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
TEL
+81-29-830-3711
Homepage URL
usuieisuke@gmail.com
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tsuchiura Kyodo General Hospital
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
Tel
+81-29-830-3711
general@tkgh.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registry study of retrospectively and prospectively acquired data from patients who underwent percutaneous coronary intervention
Management information
Registered date
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064069
